check_circleStudy Completed

Prostate Cancer, Ovarian Cancer

Bayer Identifier:

91695

ClinicalTrials.gov Identifier:

NCT00751205

EudraCT Number:

2008-000879-26

EU CT Number:

Not Available
Prevention of Sagopilone-induced neurotoxicity with Acetyl-L-Carnitine (ALC)

Trial purpose

This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient is benefitting. In addition patients will receive ALC or placebo, starting 1 week before first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone. Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be determined by the incidence of all grades of peripheral neuropathy with the results of a patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined by the tumor response.

Key Participants Requirements

Sex

Both

Age

18 - 70 Years
  • - Males or females aged >/= 18 years
    - Epithelial ovarian, peritoneal cavity or Fallopian
    tube cancer (except mucinous or clear cell
    tumors) or Adenocarcinoma of the prostate
    - At least 1 unidimensional measurable lesion
    (suitable for RECIST evaluation) or for patients
    without measurable disease, CA 125 levels >/= 2 times the upper limit of normal (ULN) within 3
    months and confirmed within 2 weeks prior to
    first infusion (ovarian cancer) or PSA value >/= 5 ng/mL (HRPC).
    - Progression of disease (HRPC) despite adequate androgen-inhibiting hormone therapy.
    - Progression of disease (Ovarian Cancer) or
    symptomatic relapse after previous therapy
    (elevated CA125 levels alone are insufficient for inclusion) WHO performance status 0 to 1
    - No clinical residual neuropathy (CTCAE Grade
    0 at baseline)
    - Adequate recovery from previous surgery,
    radiation, and chemotherapy (excluding alopecia)
    - Adequate function of major organs and systems.
    - Survival expectation =3 months
    - Histologically or cytologically proven:
    a) Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucionous cell tumors or clear cell tumors that have a clear cell component of >33%)
  • - Symptomatic brain metastases requiring whole-
    brain irradiation
    - Any concomitant malignancy: the following exceptions are allowed: Non-melanoma skin
    cancer, Carcinoma in situ of the cervix, Malignancy with definitive treatment >/= 5 years ago without relapse.
    - Diabetes mellitus (even if controlled only by
    special diet)
    - History of chronic hepatitis B or C, or known
    HIV infection
    - Seizure disorder requiring medication (such as
    steroids or anti-epileptics)
    - Inability to swallow oral medications
    - Prior treatment with epothilones
    - Concomitant use of neurotoxic drugs
    - Concomitant use of compounds that have
    potentially positive effects towards symptoms
    of neuropathy

Trial summary

Enrollment Goal
150
Trial Dates
August 2008 - August 2010
Phase
Phase 2
Could I Receive a placebo
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
Universitätsklinikum EssenEssen, 45122, Germany
Completed
Klinikum SüdstadtRostock, 18059, Germany
Completed
Centre René GauducheauNantes, 44805, France
Completed
Centre René Gauducheau - NantesNANTES, 44805, France
Completed
Diaconesses Croix Saint Simon - ParisParis, 75012, France
Completed
Centre Val d'Aurelle - MontpellierMONTPELLIER CEDEX, 34298, France
Completed
IRST Istituto Scientifico Romagnolo per studio e cura TumoriMeldola, 47014, Italy
Completed
AUSL Rimini - Emilia RomagnaRimini, 47900, Italy
Completed
Academisch Ziekenhuis MaastrichtMaastricht, 6229 HX, Netherlands
Completed
Vrije Universiteit Medisch CentrumAMSTERDAM, 1081 HV, Netherlands
Completed
Universitätsklinikum EssenEssen, 45147, Germany
Completed
Otto-von-Guericke-Universität MagdeburgMagdeburg, 38108, Germany
Completed
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Completed
Mount Vernon HospitalNorthwood, HA6 2RN, United Kingdom
Completed
Leicester Royal InfirmaryLeicester, LE1 5WW, United Kingdom
Completed
Centre Francois BaclesseCaen, 14076, France
Completed
Institut Gustave Roussy - VillejuifVILLEJUIF, 94805, France
Completed
A.O.U. di BolognaBologna, 40138, Italy
Completed
A.O. Sant'AndreaRoma, 00189, Italy
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Nederlands Kanker InstituutAmsterdam, 1066 CX, Netherlands
Completed
Leids Universitair Medisch CentrumLeiden, 2333 ZA, Netherlands

Primary Outcome

  • Overall incidence of peripheral neuropathy (any grade) during at most 6 cycles of Sagopilone treatment, based on the Adverse Events.
    date_rangeTime Frame:
    Start of Sagopilone treatment until at most 6 cycles + 1 month.
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Efficacy of ALC: incidence of neuropathy of grade 3 or 4, time to onset of neuropathy, duration of neuropathy.
    date_rangeTime Frame:
    Start of treatment to safety Follow-up
    enhanced_encryption
    Safety Issue:
    yes
  • Efficacy of ALC: Percentage of discontinuations due to neuropathy.
    date_rangeTime Frame:
    Start of treatment to safety Follow-up
    enhanced_encryption
    Safety Issue:
    no
  • Safety of Sagopilone in combination with ALC.
    date_rangeTime Frame:
    Baseline to Safety follow-up
    enhanced_encryption
    Safety Issue:
    yes
  • Efficacy of Sagopilone: 'best overall response' according to modRECIST criteria
    date_rangeTime Frame:
    Start treatment to End of Treatment
    enhanced_encryption
    Safety Issue:
    no
  • Efficacy of Sagopilone: 'best overall response' according to CA-125 or PSA response
    date_rangeTime Frame:
    Start treatment to End of Treatment
    enhanced_encryption
    Safety Issue:
    no
  • Efficacy of Sagopilone: Time to disease progression, Progression-free survival
    date_rangeTime Frame:
    Start treatment to Progression or Death
    enhanced_encryption
    Safety Issue:
    no
  • Efficacy of Sagopilone: Duration of response
    date_rangeTime Frame:
    Start treatment to Progression or Death
    enhanced_encryption
    Safety Issue:
    no
  • Efficacy of Sagopilone: WHO performance status.
    date_rangeTime Frame:
    Screening to end of Treatment
    enhanced_encryption
    Safety Issue:
    no
  • Pharmacokinetic: Sagopilone concentrations (optional)
    date_rangeTime Frame:
    Day 1,2,3,5,15 of cycle 1 and day2
    enhanced_encryption
    Safety Issue:
    no
  • Pharmacokinetic: ALC concentrations
    date_rangeTime Frame:
    radomisation, day 1 of cycle 1 and 2
    enhanced_encryption
    Safety Issue:
    no
  • Pharmacogenomics (optional): in tumor tissue, blood and ascites
    date_rangeTime Frame:
    Blood sample at screening, tissue sample and ascites whenever available
    enhanced_encryption
    Safety Issue:
    no

Trial design

(REASON) Double-blind, Randomized phase II study to Evaluate the safety and efficacy of Acetyl-l-carnitine in the prevention of Sagopilone-induced peripheral Neuropathy.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe